Withdrawal of consent: Difference between revisions
Jump to navigation
Jump to search
New page: Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 ... |
No edit summary |
||
| Line 1: | Line 1: | ||
{{CMG}} | |||
The official FDA guidelines for sponsors and clinical investigators state: | The official FDA guidelines for sponsors and clinical investigators state: | ||
Revision as of 18:59, 21 July 2011
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
The official FDA guidelines for sponsors and clinical investigators state:
"If a subject withdraws from the interventional portion of the study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent. However an investigator may review study data related to the subject prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status." Template:WH Template:WS